The effect of group spiritual care on adaptability and Self-Confidence
among adolescents with type 1 diabetes.
Design
This is an experimental clinical trial study that 52 adolescents with type 1 diabetes who are eligible for inclusion in the study are selected in a targeted manner, but their assignment is done randomly in two groups with the help of a random number table.
Settings and conduct
After verifying the validity of the package of spiritual care by a group of specialists inside and outside the country and passing the spiritual care workshop by researcher, the spiritual care program was conducted by the researcher through group education at the Diabetes Association for six consecutive days. Each session lasted 45-60 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 12 to 18 years old; having type 1 diabetes; being Muslim; having no other disease than diabetes; receiving insulin; living with the parents. Exclusion criteria: Teens aren't able to participate in research and collaborate.
Intervention groups
26 adolescents with type 1 diabetes who fulfilled inclusion criteria were included in the control group and they did not take any action, and 26 of those who had inclusion criteria were included in the intervention group and they received a spiritual care program in the form group meetings for 6 consecutive days.
Main outcome variables
Compatibility with disease, Self Confidence.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171107037295N1
Registration date:2017-12-01, 1396/09/10
Registration timing:registered_while_recruiting
Last update:2017-12-01, 1396/09/10
Update count:0
Registration date
2017-12-01, 1396/09/10
Registrant information
Name
Sahar Fallahi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3872 0211
Email address
s_falahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences and Health Services
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group spiritual care on adaptability and self-esteem among adolescents with diabetes type 1
Public title
The effect of spiritual care on diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being at the age of 12 to 18 years
being Muslim
passing minimum six months of medical diagnosis of diabetes type 1
not involving in a tense experience (parental separation, loss of one close family member over the past year)
There is no specific disease other than diabetes
Receiving insulin
Exclusion criteria:
Teens who aren't able to participate in research and collaborate.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Street address
Daneshgah square (former Evin Square), Velenjak, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.SBMUPHNM.1395.639
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10-E14
ICD-10 code description
IV Endocrine, nutritional and metabolic diseases.
Primary outcomes
1
Description
adaptability
Timepoint
Before the intervention- after the intervention- 3 weeks after the intervention.
Method of measurement
Lazarus and Fulkman Compatibility Questionnaire.
2
Description
Self Confidence
Timepoint
Before intervention - after intervention - 3 weeks after intervention.
Method of measurement
Rosenberg Confidence Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention group includes adolescents with type 1 diabetes who receive spiritual care. The spiritual care will be provided through a package which its content is confirmed by internal and external specialists. After passing the spiritual care workshop by researcher the spiritual care will be run through six 45-60 minute sessions during 6 days, at the Sanandaj Diabetes Association. The intervention is briefly summarized as follows: Familiarity with adolescents and the expression of goals, spiritual evaluation and identifying needs and concerns of adolescents, promoting beliefs and encouraging religious practices, expressing promising content, ending session. At the beginning and the end of the intervention, research tools are distributed among adolescents.
Category
Other
2
Description
Control group: The control group includes adolescents with type 1 diabetes at the Sanandaj Diabetes Association, which has criteria for entering the study and do not receive any interventions (no additional work).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Diabetes Association
Full name of responsible person
دکتر خسرو خسروی کردستانی
Street address
Maadar square, Besat Boulevard, Sanandaj, Kurdistan Province, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6616754931
Phone
+98 87 3323 5163
Fax
+98 87 3323 5163
Email
info@diabetes-sanandaj.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Shirinabadi Farahani Azam
Street address
Valiasr - Niayesh Crossroad, Valiasr street.ر
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Email
farahani1381@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Fallahi
Position
Master student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr - Niayesh Crossroad, Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Fax
Email
s1394.falahi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Azam Shirinabadi Farahani
Position
Ph.D. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr - Niayesh Crossroad, Valiasr street.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Fax
Email
farahani1381@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Fallahi
Position
Master student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr - Niayesh Crossroad, Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Fax
Email
s1394.falahi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available